A Study of TCD601 (siplizumab) in New Onset Type 1 Diabetes Patients

Last updated: February 28, 2025
Sponsor: ITB-Med LLC
Overall Status: Active - Not Recruiting

Phase

2

Condition

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Diabetes Prevention

Treatment

TCD601

Placebo

Clinical Study ID

NCT06025110
TCD601F201
  • Ages 18-45
  • All Genders

Study Summary

The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to understand the study requirements and provide written informed consentbefore any study assessment is performed

  • Male or female patients ≥ 18 to 45 years of age

  • A diagnosis of type 1 diabetes

Exclusion

Exclusion Criteria:

  • Women who are pregnant, lactating, or planning on pregnancy during the study

  • History of cancer

  • History of heart disease

  • Recent infection

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: TCD601
Phase: 2
Study Start date:
January 23, 2023
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • UZ Brussel

    Brussel, 1090
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • CHU Grenoble Alps

    Grenoble, 38043
    France

    Site Not Available

  • Université Paris Cité

    Paris, 75014
    France

    Site Not Available

  • AUF DER BULT Kinder- und Jugendkrankenhaus

    Hanover, 30173
    Germany

    Site Not Available

  • Institut für Diabetesforschung Münster GmbH

    Münster, 48145
    Germany

    Site Not Available

  • Profil Institute for Metabolic Research

    Neuss, D-41460
    Germany

    Site Not Available

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro, 88100
    Italy

    Site Not Available

  • Luigi Sacco Hospital

    Milan, 20157
    Italy

    Site Not Available

  • San Raffaele Hospital

    Milan, 20132
    Italy

    Site Not Available

  • University of Pisa

    Pisa, 56124
    Italy

    Site Not Available

  • University of Siena

    Siena, 53100
    Italy

    Site Not Available

  • EMC Silesia Katowice

    Katowice, 40-353
    Poland

    Site Not Available

  • EMC Piaseczno

    Piaseczno, 05-500
    Poland

    Site Not Available

  • Central Clinical Hospital of the Ministry of Interior and Administration

    Warsaw, 02-507
    Poland

    Site Not Available

  • Military Clinical Hospital

    Wrocław, 53-114
    Poland

    Site Not Available

  • Medical University of Lodz

    Łódź, 92-213
    Poland

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge

    Barcelona, 08907
    Spain

    Site Not Available

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007
    Spain

    Site Not Available

  • Hospital General de Segovia

    Segovia, 40002
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Site Not Available

  • Karolinska University Hosptial

    Stockholm,
    Sweden

    Site Not Available

  • Dorset County Hospital NHS Foundation Trust

    Dorchester, Dorset DT1 2JY
    United Kingdom

    Site Not Available

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool, Merseyside L7 8YE
    United Kingdom

    Site Not Available

  • University of Birmingham

    Birmingham,
    United Kingdom

    Site Not Available

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, BD9 6DA
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge,
    United Kingdom

    Site Not Available

  • University Hospitals of Derby and Burton NHS Foundation Trust

    Derby,
    United Kingdom

    Site Not Available

  • Ninewells Hospital

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Guy's and St. Thomas' NHS Foundation Trust

    London,
    United Kingdom

    Site Not Available

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • East Kent Hospitals University NHS Foundation Trust

    Margate, CT9 4AN
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • Northern Care Alliance NHS Foundation Trust

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Swansea Bay University Health Board

    Swansea,
    United Kingdom

    Site Not Available

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